Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Continental Soft Lens, Inc. · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K990011 | CONTINENTAL 45 TORIC SOFT (HYDROPHILIC) CONTACT LENSES FOR D | Continental Soft Lens, Inc. | 1999-05-11 | 127 | 0 |
| K943490 | CONTINENTAL 45 (HEFILCON A) SPHERICAL & ASPHERIC CONTACT LEN | Continental Soft Lens, Inc. | 1994-08-11 | 23 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda